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Tag: determine CSF outflow needs

The DiaCeph Test was created in 1997 to evaluate CNS shunt performance in patients with the disorder, hydrocephalus. It is a mathematical formula and algorithm born out of my experiences as a patient and patient advocate, and from 18 years of experience in diagnostic nuclear medicine, including, with hydrocephalus and software.

DiaCeph’s algorithm uses a weighted probability of a patient user’s clinical complaints, or complaint markers, to the most likely of (17) types of malfunctions that can occur with a CNS shunt. The results are displayed and ranked in order of probability. In addition, the markers are plotted on time vs complaint level graphs, where they are compared to the patient’s baseline markers and earlier shunt outcomes. The impetus for creating the DiaCeph Test came from my poor post surgical outcomes and frustrating diagnostic experiences as a patient user for hydrocephalus following a 1992 auto accident. I’ve used my DiaCeph methodology (paper forms) to track the shunt outcomes, make shunt valve pressure predictions, and diagnose shunt malfunctions for my last (8) shunt revisions. Still in 2016, there is no reliable diagnostic means to determine how well a CNS shunt is working. The DiaCeph Test could readily be made into a mobile app, providing the necessary funding, administrative, and FDA regulatory requirements can be satisfied.

The DiaCeph paper methodology could easily be produced as a mobile data app.

DiaCeph Test born out of FDA Petition/Unmet Need in Hydrocephalus

Hydrocephalus is the leading neurosurgical disorder in children, often resulting as developmental changes in utero, shortly after delivery, or by brain cysts early in life. It occurs in seniors in the form called NPH, or normal pressure hydrocephalus, and in the past NPH was often confused with dementia and/or Parkinson’s Disease. It can also occur following trauma and tumors in the brain. It is most often treated by surgical insertion of a “CNS shunt,” which the patient will live with the remainder of their life, and which are very problematic technology often requiring surgical replacement.

My DiaCeph data app slide above is from my original (1997) design of the DiaCeph Test. This came out of my research in authoring an important 1996 FDA petition on anti-siphon shunts. I was familiar with hydrocephalus and CNS shunts from my many years of diagnostic work in nuclear medicine, where I worked with software and regularly wrote procedures, and occasionally basic software code.

Stephen Dolle invented his DiaCeph Test following his 1996 FDA petition that was then used to direct this 1998 shunt surgery

I had been a patient user of CNS Delta valve shuntsfor hydrocephalus since 1992, and had experienced unexplained poor outcomes from three surgeries over a period of four years. In 1996, I learned of a new critical study published in the Journal of Neurosurgery by a well known Japanese neurosurgery group, that cited specific safety & performance issues with Medtronic PS Medical Delta Shunts & Anti-siphon devicesthat seemed remarkably similar to complaints I was experiencing. Sadly, neither my treating physicians, shunt manufacturers, or the Food & Drug Administration were able to help me.

In November of 1996, I petitioned the U.S. Food & Drug Administration (FDA) Center for Devices and Radiological Health with this important FDA petition on CNS anti-siphon shunts, concerning problematic CNS shunt technology which I had been implanted for 4 years, and was experiencing unexplained poor outcomes. It was in 1996 that a critical study was published in the Journal of Neurosurgery regarding the risks of using anti-siphon devices. The petition took me almost a year to prepare, and required that I obtain supporting FDA records on microfiche, obtain and learn the federal government’s applicable CFRs to CNS shunts, pay a librarian consultant for many of the (52) cited studies, and carry on correspondence with Ralph Nader’s group Public Citizen.

What I learned, was that between 1976-1996, many thousands of patients had been implanted with MedtronicDelta valves & Heyer-Schulte anti-siphon shunts and that about one-third of these were experiencing the kinds of poor outcomes as cited in the Higashi et. al. J. of Neurosurgery study. Higashi and his team described these shunt performance issues as “functional obstructions” of the CNS shunt system, most of which occured in the upright posture. However, some were reported with sleeping and other external pressure over the body of the shunt valve. What made the problem particularly challenging, was that there was no available (in-vivo) diagnostic test to identify and quantify the issue in patients. Available CT/MRI and shunt patency testing was usually “negative” for shunt malfunction, which is termed a “false negative.” Higashi and his team then cited the need for a new type of diagnostic test to identify these shunt outcomes issues in affected patients. Once I authored my petition, my next challenge was in creating a new type of test to evaluate these shunt performance issues.

I sought out a method to chart & analyze non-invasive clinical markers in hydrocephalus in different postures, and during different times of the day. This was 1997, and the same year researchers at the U. of Pittsburgh and Henry Ford Institute, were quietly doing this to monitor sports concussion. It took me more than a year, during which I also consulted aerospace scientists on possible math formulas. Once it passed the first proof of design phase, I expanded my test to evaluate any type of problem with any type of CNS shunt. And then I aptly named it the DiaCeph Test. Dia– meaning to diagnose. And Ceph– meaning of the brain. The design and proof of concept were completed in Sept. of 1997. And then I began using it to evaluate my Delta shunt for corrective revision.

Initially, I was going to “give my method away” to one of the shunt manufacturers. But it was a friend from little league baseball who convinced me to try and PATENT it. Which I did via the law firm Knobbe Martens Olson & Bear. The photo above was taken just days after my Feb. 1998 shunt revision where I used the DiaCeph Test to help determine which type of shunt would fit my CSF outflow needs.

My experience in nuclear medicineand working with hydrocephalus and diagnostic software proved invaluable in the creation of the DiaCeph Test. Over my 18 years of nuclear medicine (beginning in 1975), I had authored hundreds of diagnostic procedures, set up hospital imaging procedures, started and run an imaging company, and provided diagnostics for a wide range of medical conditions. Two of those tests for hydrocephalus were cisternograms and shuntograms.

In 1997, my DiaCeph Test was so new, it didn’t have a category name. But today, these type of applications are widely termed, “mHealth.” As such, my DiaCeph Test design was one of the earliest mHealth tests, and remains state of the art still in 2016. But, designing it was no simple task. I had to contend with frequent cognitive or memory difficulties, shunt malfunctions, terrible headaches, and lack of funding.

In 1998, I filed my full patent on the DiaCeph Test and formed the start-up, DiaCeph, Inc. DiaCeph was to be a dedicated PDA app, like the Palm Pilot that had just become available. The Internet at that time was just mature enough then to allow patient data and results to be sync’d with a PC either at the patient’s home, or at the physician’s office. I proposed how a server could allow uploading & sharing of patient results.

DiaCeph can analyze non-invasive user data and render a diagnosis of the type of shunt malfunction. I created a series of clinical markers (as can is seen in the slide above), and by establishing a patient’s baseline normal values, incident results could be compared and produce a diagnosis based on the change from normal. Where there was no comparitive data, the program still aggregated resulting data and compared it with the most likely data known by the program for the different types of shunt malfunction. I was advised that patients not be given access to the results by FDA and others involved in the project. Today we know its best to give patients this information. Below, is earlier web site information on the DiaCeph Test. Below that, an Orange County Business Journal‘s 1999 story about the DiaCeph Test entitled, “The Accidental Inventor.”

Stephen Dolle, Dr. Eldon Foltz, and Stephen Natawpski of Knobbe Martens are interviewed by the Orange County Business Journal regarding the invention of the DiaCeph Test, and Stephen’s FDA efforts in Washington, D.C.Stephen Dolle interviewed in the Orange County Business Journal for his FDA efforts and DiaCeph Test invention Page 2

DiaCeph underwent initial evaluation and development at the University of California Irvine (UCI). My lead physician was the long time neurosurgeon and professor, Dr. Eldon Foltz, who was excited about the DiaCeph Test and offered to mentor me. He shared he had been trying to develop a similar test since 1980. Dr. Foltz helped me form a board of medical advisers at UCI, and introduced me as an mHealth pioneer.

After the FDA granted my shunt petition in Sept. 1998, I was invited to attend the FDA’s STAMP Technology Conference in Bethesda, MD, which was to address shunt safety issues as cited in my petition. However, the conference never did! Nor were these CNS anti-siphon shunt challenges discussed, nor DiaCeph mHealth concept. And neither was I was not invited to appear on the conference panel, despite being the person who helped create the conference. As a result, my DiaCeph Test and similar solutions never received the exposure they deserved. It no doubt hurt prospects for the DiaCeph Test at a time it was badly needed, and amid my limited resources as a patient developer.

As time went on, I looked for new novel ways to utilize the DiaCeph methodology. Below, are SlideShare.net slides of new (July 2016) DiaCeph Test NPH Instructions, a NPH 6-Marker Form, and a new Chronological Outcomes Form or “flow chart” for creating a patient record of many years with various shunts, opening pressure settings, and hydrocephalus outcomes (complaints/status) in a patient. There are instructions on how to complete the historical flow chart in the back of the NPH instructions.

These materials are FREE to use. But if you have questions or would like my assistance with monitoring or related hydrocephalus and shunt issues, please contact me directly. My consulting rates are $125 per hour.

Diaceph 5 day 7 marker NPH hydrocephalus shunt monitoring form

DiaCeph Test MONITORING INSTRUCTIONS

DiaCeph Test MONITORING FORM

DiaCeph Test FLOW CHART

DiaCeph, Inc. as a Brain Software Company

By 1999, I was exploring other brain apps & software and making plans for this as part of DiaCeph, Inc., to be an innovator in this space. This was prior to the advent of Google apps, social networking, and mobile tech leaders like Samsung and Apple. At that time, the only two mHealth apps under consideration were by Aetna’s health division for CHF and asthma. I was also in communication with Hewlett Packard, Microsoft, the Coleman Institute, and other institutions involved in assistive cognitive technologies. I presented DiaCeph to a number of university centers and medical device companies. But I could not get any committments to partner or fund it. Apparently, no one saw my vision.

By 2003, I had begun to move on to other neuroscience interests. My brain also remained significantly swollen due to unresolved and mis-understood hydrocephalus, and kept me on disability, working only part time. I could not get a neurosurgeon to undertake additional surgery without diagnostic documentation. It was a Catch 22! I believe if the DiaCeph Test were available then, it would have answered these diagnostic questions.

In the end, the DiaCeph Test was never made into a PDA app due to lack of funding, FDA regulatory barriers (costs), and lack of support from medical device companies in the field of neurosurgery. However, DiaCeph could still be produced today as a mobile data app. I wrote up a “creative brief” in 2014. The challenge now lies mainly in the FDA regulatory costs of mHealth apps, where estimates have said to be in excess of $1M. It is doubtful this cost could ever be recouped in sales of the app. So I prepared wider prospects for other neurological apps in my expanded Creative Brief.

Hydrocephalus today still faces considerable mis-diagnoses due to unavailability of imaging and mHealth solutions. Radiologists regularly mis-interpret CT and MRI brain scans, which leads to undiagnosed shunt malfunction and incorrect settings of programmable shunts. This in turn has resulted in significant quality of life issues and costs for patients living with hydrocephalus.

Below, is a screen shotof a CT/MRI mHealth Display method I’ve been using since about 2002. This helps to organize CT and MRI scans into useful formats for review by your physicians, especially when there are many scans over a period of years. At present, the link is to a blog I authored on LinkedIn. I hope to sometime elaborate further on this in a new company blog. I also consult on preparing these at my same $125 per hour rate.

You should obtain CDs of all your CT/MRI brain scans. The method allows for review of 1000s of CT & MRI images by placing the most critical images in a chronoligcal sequence for comparison. These displays can also reduce interpretation medical errors.

To create these, I first create folders on my PC for each CT or MRI series. Then I export the images as JPEGs into the respective folders using the media software included in the radiology CD disc. Next, I review, select, and label the relevant images and copy them to special forlders where I arrange them in chronological order for better viewing. This format makes interpretation much more scientific, and it minimizes any human (visual) error during interpretation.

This method is particularly important in hydrocephalus care – where it is common to have dozens of studies and 1000s of CT and MRI images for review. This mHealth display method would benefit radiologists, neurologists, and neurosurgeons involved in hydrocephalus care and other care involving CT and MRI studies.

This method allows for more detailed evaluation of shunt settings, shunt performance, and shunt malfunction. I put these mHealth methods to good use in my hydrocephalus consults and shunt monitoring services.

Once you have assembled the critical MRI/CT Images Folders, they can be easily sync’d and copied to folders on your mobile phone and tablet device. Then when you see your physician, you’ve got all your CT and MRI images neatly organized for review.

Below, is a diagram of my current shunt valve, the Codman Certas valve, which was implanted in Nov. 2012. However, in May 2013, it was recalled due to stability issues during MRI exams.

Illustration of the Codman certas valve, an externally adjustable programmable CNS shunt valve with 7 pressure settings, and is used in the treatment of hydrocephalus.

The DiaCeph App today could be made as a mobile data app and text app (for use in developing countries). It would enable 24/7 monitoring of hydrocephalus and could be coupled with a variety of neurological, EEG wave, and other apps now available.

Additional Resources on Hydrocephalus Monitoring

I’ve been providing NPH/Hydrocephalus Monitoring Services & Patient Consults with DiaCeph paper forms/instructions since 2009. I also host FREE monitoring forms and information on hydrocephalus. My experience with hydrocephalus now spans 18 years of diagnostic work in nuclear medicine, and 21 years in FDA regulator affairs, CNS shunt reviews, mHealth design, cognition and assistive technology, drumming & music therapy, and global patient consults for affected individuals/families around the world.

I also host two consult reports on the top blog above (Hydrocephalus NPH Monitoring by Stephen Dolle). The first report was completed by a legally blind man. I provide each patient a custom set of forms and instructions. If an mHealth app were available, it would direct patients or users in the collection of this data, and then offer physicians the data in a finished format for earlier diagnoses, intervention, and surgery.

The Terminator is the ultimate super-hero for adults and children affected by hydrocephalus.

Early on, after I was implanted with a VP shunt for hydrocephalus, I began to seek creative comfort in stories about Super Heroes. As an inventor, I also began to equate living with a CNS shunt implant to the Terminator character in the movie of the same name. Eventually in 2013, I created a fun web site and Facebook page for hydrocephalus – where I began to write about “super-heroes” for hydrocephalus. Here I am today pictured below in a current photo following a speaking engagement. My rates are very reasonable, and I have a list of topics I speak on. Contact me for more information of this.

I have undergone 12 brain operations, or shunt revisions as they are termed, since my initial diagnosis in 1992. I became a shunt device, hydrocephalus “expert,” and early inventor of an mHealth mobile app, the DiaCeph Test. It was my 1996 petition to the Food & Drug Administration as a CNS shunt patient that led to my designing the DiaCeph Test. My efforts then helped bring about the 1999 International STAMP Conference in Washington D.C. At that time, many in industry felt the conference and FDA upholding my petition were heavy handed actions designed to hinder innovation in industry. But in the years since, it has been shown to be just the opposite, that without mHealth tools and patient engagement, there will be less innovation, more challenges for physicians, higher costs & disability rates for patients, and a lower quality of life for those affected. It is time for industry, FDA, and Congress to stand in our shoes! In 2015, I also published my current health challenges with hydrocephalus and a related neuromuscular disorder on my blog in this case study.

Many of the CNS shunts in use today are programmable shunts, where pressure and flow rate can be externally adjusted for each patient. But, many of these devices have been susceptible to inadvertent reprogramming from household appliances and technology magnetic fields. At present, FDA does not allow patients to own the reader or programming tool to help manage these unforeseen events. I would love to develop a mobile app or accessory tool to allow patients to check the setting of their shunts.

Other Brain Apps

I use other brain apps on the Android Play Store to help with the management of hydrocephalus, including, a Decibel Meter, EMF Detector by Smart Tools, and a Weather & Barometric Pressure app by Elecont Software. The more recent availability of EEG readers has further elevated the prospects of brain apps in neurological care, and in meditation and mindfulness – SEE my other blogs for information on these.

I advise and write about brain apps, often helpful in hydrocephalus and other neurological disorders. In this blog, I share tips on design & using apps:

The Elecont HD app provides an hour by hour barometric pressure reading that can be used to help manage migraine headache.

DiaCeph Development Costs and Other Barriers

Estimates to develop a hydrocephalus mHealth app are as high as $1M. Requirements by FDA are driving these high costs. In developing countries, FDA guidance does not come into play. And for those regions, a “text app” version of the mobile data software could be created to do monitoring on a standard mobile phone, and text the results to a regional hospital or clinic. My DiaCeph Creative Brief is currently 16 pages. I understand this is too large for most reviews. So I am preparing a “short” and “long” version.

I understand there are organizations who could help develop or fund my mHealth app project. My wish would be to work with a mHealth software group and provide the guidance and expertise to develop the DiaCeph app, and then advise on other applications.

Currently, development of mHealth apps for disease management have become a political ball game between patient advocates, the Food & Drug Administration or FDA (backed by big corporations), and Congress. Earlier this year, a bill was introduced in Congress by Senators Deb Fischer (R-Neb.) and Angus King (I-Maine), identified as the PROTECT Act(Preventing Regulatory Overreach To Enhance Care Technology). The bill has garnered the support of IBM, athenahealth, the Software & Information Industry Association, and Newborn Coalition and McKesson.

Shortly after introducing the act, the legislators penned an editorial in USA Today calling FDA’s regulatory process burdensome and a hindrance to innovation. One organization, with connections to big pharma lobyists, calling itself the mHealth Regulatory Coalition (MRC), has come out and opposed it. But I suspect they don’t live with a medical condition like hydrocephalus, that would benefit from these mHealth app innovations.

Many individuals with hydrocephalus have had 100 and 200 surgeries, and live a very poor quality of life. Quality of live, and unnecessary brain surgeries, would no doubt be improved with the availability of mHealth app diagnostics.

If you are interested in development of the DiaCeph Test, obtaining a hydrocephalus consult, mHealth consulting, or my speaking at an event, please contact via the information below.